May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

May 4, 2012 - See Notice NOT-MH-12-022. Notice of Additional Areas of Research Interest.

This Funding Opportunity Announcement (FOA) is designed to
improve the quality and quantity of research related to emergency medical
services for children (EMSC), with the goal of reducing morbidity and
mortality in children through improved care delivery. This FOA invites the
submission of applications dealing with the following areas of research
included under the term EMSC: prevention research to reduce the need for
emergency care; clinical research to ensure that children receive
high-quality and appropriate medical, nursing and mental health care in an
emergency; health systems research, from pre-hospital care, to the emergency
department, to in-patient care and return to the community; models to improve
service and cost efficiency in pediatric emergency care; and methodological
studies to improve the quality of research conducted.

Key Dates

Posted Date

March 29, 2012

Open Date (Earliest Submission Date)

May 5, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide, except where instructed to do otherwise
(in this FOA or in a Notice from the NIH Guide for Grants and
Contracts). Conformance to all requirements (both in the
Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

This Funding Opportunity Announcement (FOA) invites
applications that will improve the quality and quantity of research related to
emergency medical services for children (EMSC), with the goal of reducing
morbidity and mortality in children through improved care delivery.

Objectives

Injury is the leading cause of death in the United States
for people ages 1 to 44 years with more than 180,000 deaths from injury each
year or the equivalent of one person dying every three minutes. This is just
the tip of the iceberg, as more than 2.8 million people are hospitalized with
injuries each year, and more than 29 million individuals are treated in
emergency departments for injuries each year according to the United States
Centers for Disease Control and Prevention. Getting timely and effective
medical care can be life saving in certain circumstances. Emergency medical
services for children (EMSC) can differ significantly from services created for
adults. Research on EMSC has lagged behind similar research for the adult
population. Seven broad areas of research on emergency medical services for
children, previously identified and still relevant, include: (1) building the
evidence base for clinical aspects of emergencies and emergency care; (2) improving
data collection and evaluation systems in EMSC; (3) patient outcomes and
outcome measures in pediatric emergency care; (4) costs and cost-effectiveness;
(5) system organization, configuration, and operation to provide optimal care;
(6) effective approaches to education and training, including re-training and
skill retention; and (7) assuring pediatric safety and quality in emergency
care.

Background

In 2003, the Institute of Medicine Committee on the Future
of Emergency Care in the United States Health System identified a need to
enhance the research base for emergency care. In 2006, the IOM released the
Future of Emergency Care, a series of reports that included Emergency Medical
Services at the Crossroads, Hospital Based Emergency Care: At the Breaking
Point, and Emergency Care for Children: Growing Pains (http://www.iom.edu/CMS/3809/16107.aspx ). Gaps were identified in basic, translational, and health services research
in the area of emergency care. The reports comprehensively described the
fragmented system of emergency care with emphasis in the pediatric report on
the uneven and disparate nature of emergency care for children in the United
States. Key recommendations included: (a) improve coordination of care, (b)
regionalize specialty pediatric medical care, (c) increase accountability, (d)
arm the emergency care workforce with pediatric knowledge and skills, (e)
enhance patient safety advancements in technology and information systems, (f)
improve emergency preparedness for children involved in disasters, and (g)
build an evidence base for pediatric emergency care.

In 2009, the National Institutes of Health (NIH) sought the
input from health professionals on the “needs and challenges in the field of
emergency medicine research” through a series of roundtables on emergency care
research. Gaps were identified in the need for rigorous out-of-hospital
research and the translation of existing research findings in adults to children.
The Roundtable on Emergency Trauma Research identified a gap in standard
consent and enrollment processes for patients similar to that of inpatient
units and a lack of expertise in the area of EMSC on NIH study sections. This
roundtable also discussed the need to link multiple databases to incorporate
pre-hospital, emergency department, and in-hospital data to conduct certain
types of research trials. The NIH Medical-Surgical Emergency Research
Roundtable highlighted the need for pediatric focused studies on cardiac
arrest, noting that underlying differences between children and adults influence
the delivery of CPR in children. Additionally, the effects of interventions
that have been shown to be successful in adults such as the use of
resuscitation fluids, drugs, and therapeutic hypothermia have not been
adequately studied in children.

The National Commission on Children and Disasters (NCCD)
2010 Report to the President and Congress issued recommendations to address
gaps in laws, regulations, policies, and programs that fail to meet the needs
of children during disasters. Most compelling in its recommendations was the
need to have a robust mental health system supported through research in place
for children following a disaster and an aggressive mental health research
agenda that includes plans to evaluate the services and interventions provided
to children exposed to trauma. The NCCD Report also recommended improving the
ability of emergency medical services to provide adequate pre-hospital care for
children at all times and during disasters through the creation of pediatric
EMS performance measures that incorporate a strong emergency preparedness
component.

Significant differences between the health care needs of
children and adults mean that the dramatic changes now affecting the
organization, financing, and delivery of health services may have differing
effects on children than on adults. Children are different from adults in their
distinct developmental vulnerabilities and strengths, their patterns of use of
health services, and their dependence on others for access to care and
financial resources. Similarly, differences exist between emergency medical
services for children compared to those for adults. Research in emergency
medical services for children is essential to validate the clinical merit of
care that is given, to identify better kinds of care, to devise better ways to
deliver that care, and to learn where best to direct prevention activities. The
use, costs, quality, accessibility, delivery, organization, financing, and
outcomes of physical and mental health care services must be evaluated to
increase understanding of the structure, processes, and effects of health
services for both individual children and populations of children.

The NICHD conducts and supports laboratory, clinical,
epidemiological, and translational research on a variety of topics to assure
that every individual is born healthy, is born wanted, and has the opportunity
to fulfill his or her potential for a healthy life unhampered by disease or
disability. The NICHD has grant programs that deal with behavioral and
developmental aspects of pediatric health promotion, disease prevention, and
injury prevention, child abuse and maltreatment, pharmaceuticals for children,
pediatric critical care and rehabilitation, and traumatic brain injury that
share interest in EMSC research.

Specific Areas of Research Interest for NICHD include but
are not limited to the following:

Demonstrate the efficacy and effectiveness of interventions
provided to children in an emergency setting, including pre-hospital
interventions;

Develop an evidence base for clinical aspects of emergencies and
emergency care;

Demonstrate effective approaches to education and training,
including re-training and skill retention of emergency care personnel;

Identify and/or develop effective disaster preparedness and
response approaches for all children including those with disabilities, special
health care needs, emotional or psychological risk profiles, or living in
disadvantaged situations;

Evaluate emergency medical services and systems of care for
pediatric patients in terms of availability, effectiveness, and outcomes, using
prospective cohort models to discover and describe potential systematic
deficits that impede optimal delivery and outcome of emergency medical care;

Assess mechanisms by which emergency medical service delivery for
children might be altered or enhanced to ensure safety, efficacy and
availability of services appropriate for children's age and physiologic condition;

Evaluate access to and quality of emergency care and follow-up
services for suicidal or self-injurious children and adolescents, and their
family members, with special emphasis on transdisciplinary delivery of
emergency services;

Evaluate studies designed to improve diagnosis (including the use
of decision trees and diagnostic aids), treatment, and health outcomes of
children in need of emergent assessment and treatment;

Evaluate studies to improve diagnosis, reporting, treatment, and
follow up of child abuse or neglect and youth violence through programs
instituted in emergency departments or in pre-hospital care;

Evaluate the emergency department as a site for counseling on
health-risk behaviors, health promotion, and intentional and unintentional
injury prevention;

Investigate medical and behavioral aspects of emergency medical
treatment of children with illness or injury documenting management of pain,
stress, and/or adherence to treatment or completion of indicated follow-up care;

Evaluate disparities in access to and quality of emergency
medical services for children based on socioeconomic status, race, ethnicity,
gender, gender identity, language, or health literacy;

Develop and evaluate the scientific basis of pediatric
resuscitation practice with the goal of improving neurodevelopmental outcomes
in injured or acutely ill children;

Assess innovative approaches based on the translation of recent
basic science studies into clinical practice, such as new methods of
circulatory and ventilatory support, and newer strategic applications of more
conventional methodologies;

Evaluate the link between acute interventions and chronic illness
and disability in children across the developmental trajectory;

Understand pediatric traumatic brain injury and therapeutic
strategies in emergency services to enhance survival and minimize disability in
children with head injuries;

Conduct descriptive studies of the epidemiology of critical
illness and injury in childhood, particularly those that may elucidate the
health disparities sustained by those in racial and ethnic groups especially
impacted by childhood critical illness, injury, and disability;

Evaluate basic and clinical pharmacology studies related to
efficacy, safety, dosing and pharmacogenomics of medications used in the
prevention and treatment of emergency-related conditions in children;

Evaluate the need for pediatric formulations and devices for use
in emergency situations;

Investigate developmental aspects of emergency treatment
algorithms in efficacy and safety, in children, pregnant women and the unborn
child;

Study long-term developmental outcomes of children and pregnant
women treated with pharmacologic agents, including anesthetics and analgesics,
for emergency indications.

National
Institute of Mental Health (NIMH; http://www.nimh.nih.gov)

The National Institute of Mental Health (NIMH) has active
grant programs in the areas of developmental psychopathology, traumatic stress,
mental health services research, and prevention, and treatment of mental
disorders in children and adolescents. With growing numbers of children and
adolescents seeking mental health care in emergency service settings,
epidemiological research characterizing the nature and scope of this phenomenon
and tracking the psychological sequelae of patients seen in emergency service
settings, is of great interest. Broadly, NIMH is interested in studies that
examine the quality and appropriateness of services for children and
adolescents with mental health problems who are seen for emergency medical
care, as well as the impact of the delivery of emergency care on mental health
sequelae for children. Studies focusing on the prevention of youth suicide, and
research developing and testing novel interventions to treat suicidal children
and adolescents in emergency service settings are of interest, as are studies
developing interventions to effectively link at-risk children and adolescents
to mental health services from emergency care settings. NIMH is also interested
in studies of the mental health consequences of traumatic events and the
development and testing of interventions to assist victims and survivors. Knowledge
is sought regarding the spectrum of responses to trauma and the influence that
different stressor parameters (e.g., setting, frequency, controllability,
severity) may have for pathological sequelae, treatment alternatives, and
preventive options. A major challenge to progress in developing and testing
pharmacological and psychotherapy interventions to prevent post-traumatic
sequelae is the current inability to predict which youth are at highest risk
for serious adjustment concerns. Accordingly, studies to identify risk markers
and/or to develop decision tools for guiding preventive interventions and
clinical are of interest.

Specific Areas of Research Interest for NIMH include but are
not limited to the following:

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Section
IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as
described in the SF 424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and technical
merit, and in providing an overall impact/priority score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to subjects,
2) adequacy of protection against risks, 3) potential benefits to the subjects
and others, 4) importance of the knowledge to be gained, and 5) data and safety
monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the
appropriate Scientific Review Group(s), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding
decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this
funding opportunity announcement and welcome the opportunity to answer
questions from potential applicants. Applicants are encouraged to contact
the listed program officials regarding specific questions about scientific
scope and the review venue.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.